Rhea Aripiprazole

Rhea Aripiprazole Indications/Uses

aripiprazole

Manufacturer:

Korea Otsuka

Distributor:

Philusa
Full Prescribing Info
Indications/Uses
Schizophrenia: Aripiprazole is indicated for the treatment of schizophrenia. The efficacy of Aripiprazole was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13-17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents (see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions).
Bipolar I Disorder: Acute Treatment of Manic and Mixed Episodes: Aripiprazole is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults (see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions).
Maintenance Treatment of Bipolar I Disorder: Aripiprazole is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults (see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions).
Adjunctive Treatment of Major Depressive Disorder: Aripiprazole is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode. (See Pharmacology: Pharmacodynamics: Clinical Studies: Adjunctive Treatment of Major Depressive Disorder under Actions).
Irritability Associated with Autistic Disorder: Aripiprazole is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) (see Pharmacology: Pharmacodynamics: Clinical Studies: Irritability Associated with Autistic Disorder under Actions).
Tourette's Disorder: Aripiprazole is indicated for the treatment of Tourette's disorder. Efficacy was established in one 10-week placebo-controlled trial in pediatric patients (aged 6 to 18 years) with Tourette's disorder.
Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder: Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with schizophrenia, bipolar I disorder, and irritability associated with autistic disorder is indicated as part of a total treatment program that often includes psychological, educational, and social interventions.
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